ADHERENT VISUAL STIMULATOR GOGGLES

K113785 · Anschel Technology, Inc. · GWE · Jun 6, 2012 · Neurology

Device Facts

• Record ID: K113785
• Device Name: ADHERENT VISUAL STIMULATOR GOGGLES
• Applicant: Anschel Technology, Inc.
• Product Code: GWE · Neurology
• Decision Date: Jun 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1890
• Device Class: Class 2

Intended Use

The SightSaver™ is an evoked response photic stimulator that is used to apply a visible light stimulus to a patient's eyes for use in evoked response measurements or for electroencephalogram (EEG) activation. The SightSaver™ Visual Stimulator is designed to be used in hospital and clinical settings by trained medical personnel and is for prescription use only.

Device Story

Disposable visual stimulator; utilizes embedded LEDs to flash visible light into patient's eyes; periocular adhesive foam padding; connects to external triggering and acquisition system for recording/processing responses; used in hospital/clinical settings by trained medical personnel; facilitates evoked response measurements or EEG activation; provides standardized light stimulus; improves safety via ISO 15004-2 compliance.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Embedded LED technology; disposable adhesive foam padding; periocular form factor; ISO 15004-2 compliant; controlled by external triggering/acquisition system; no internal software/algorithm.

Indications for Use

Indicated for patients requiring evoked response measurements or EEG activation via visible light stimulation. For use in hospital and clinical settings by trained medical personnel.

Regulatory Classification

Identification

An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.

Predicate Devices

• Cadwell LED Goggles (K831231)
• XLTEK LED Visual Stimulator Goggles (K011794)

Submission Summary (Full Text)

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## 510(k) Summary

ﺖ

# SightSaver™ Visual Stimulator K113785

| Applicant | Anschel Technology Inc.<br>David Anschel<br>1 Wildwood Road<br>Rocky Point, NY 11778 | |
|----------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Primary | Dr.Glen Park<br>Sr.Director, Clinical and Regulatory Affairs<br>Target Health Inc.<br>261 Madison Avenue, 24th Floor<br>New York, NY 10016<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| | Secondary | David Anschel<br>1 Wildwood Road<br>Rocky Point, NY 11778<br>Phone: [phone] |

| Device Name | SightSaver™ Visual Stimulator | | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-------------|
| Common/Usual<br>Name | SightSaver™ | | |
| Classification Names<br>/ Numbers and Code | 21 CFR<br>882.1890 | Classification Name<br>Evoked response photic stimulator | Code<br>GWE |
| Regulatory Class | II | | |
| Prescription Status | Prescription Device | | |
| Device /<br>Classification Panels | Diagnostic Neurological Devices | | |
| Predicate Devices | Cadwell LED Goggles | K831231 | |
| | XLTEK LED Visual Stimulator Goggles | K011794 | |
| Technology | Embedded LEDs (Light-emitting diodes) | | |
| Description of<br>Device | The SightSaver™ Visual Stimulator is used to expose the eyes to<br>light in order to elicit a physiological response. LEDs inside the<br>device flash light at the eye. The SightSaver™ Visual Stimulator is<br>disposable and made with specifically shaped self-sticking adhesive<br>foam padding which conforms to the periocular region of the<br>patient's face.<br><br>The SightSaver™ is designed to be connected to a triggering and<br>acquisition system which records, analyzes, or processes the<br>patient's responses.<br><br>The triggering and acquisition system is not included as part of the<br>510(k). | | |

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| Device Indications<br>for Use | The SightSaver™ is an evoked response photic stimulator that is<br>used to apply a visible light stimulus to a patient's eyes for use in<br>evoked response measurements or for electroencephalogram (EEG)<br>activation. |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The SightSaver™ Visual Stimulator is designed to be used in<br>hospital and clinical settings by trained medical personnel and is for<br>prescription use only. |

| Predicate Comparison Summary | | | |
|--------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------|------------------------------------|
| Device Name | The SightSaverTM<br>Visual Stimulator | Cadwell LED<br>Goggles | XLTek Visual<br>Stimulator Goggles |
| K Number | K113785 | K831231 | K011794 |
| Same Intended Use /<br>Indications for Use | Yes | Yes* | Yes |
| Utilizes embedded<br>LED technology to<br>flash visible light into<br>the eyes for testing<br>purposes | Yes | Yes | Yes |
| Controlled by a<br>separate triggering<br>device | Yes | Yes | Yes |
| Typical use flash<br>repetition rate: 0.5Hz -<br>1.0Hz | Yes | Yes | Yes |
| ISO 15004-2<br>compliant | Yes | No | No |

## Conclusion

The SightSaver"M Visual Stimulator has been tested to higher safety performance standards compared with the predicate devices but is the same as the predicate devices in:

- Intended use ■
- Overall design and form factor 8
- Technological characteristics l

The function and technology employed by the SightSaver™ Visual Stimulator is similar and introduces no new questions concerning safety and efficacy. Therefore, the SightSaver™ Visual Stimulator is substantially equivalent.

. 4.

* While Intended Use is the same, the specific wording of the Indications for Use was not available from the manufacturer of the Cadwell LED Goggles

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Anschel Technology Inc. c/o Dr. Glen Park Target Health Inc. 261 Madison Avenue, 24th Floor New York, NY 10016

## Re: K113785

Trade/Device Name: SightSaver™ Visual Stimulator Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: Class II Product Code: GWE Dated: June 1, 2012 Received: June 4, 2012

### Dear Dr. Park:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

JUN. - 6 2012

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Page 2 - Dr. Glen Park

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kestia Alexander

for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K113785

Device Name: SightSaver™ Visual Stimulator

Indications for Use:

The SightSaver™ is an evoked response photic stimulator that is used to apply a visible light stimulus to a patient's eyes for use in evoked response measurements or for electroencephalogram (EEG) activation.

The SightSaver™ Visual Stimulator is designed to be used in hospital and clinical THE Officaned medical personnel and is for prescription use only.

X Prescription Use

AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kmith

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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K113785 510(k) Number